Earnings Releases·Nov 12, 2026, 6:14 AM ET

enGene Therapeutics Inc. — November 2026 Earnings Summary

**Clinical Progress & Financial Position:** The company maintains a cash balance of $245.8 million with no reported revenue or earnings; the lead program, Detalimogene, achieved a 56% Any Time Complete Response rate in Pivotal Cohort 1 (up from 54% in April 2026) and a 24% 12-Month Complete Response rate (up from 13% in April 2026).
**Regulatory & Development Timeline:** Management plans to initiate the Biologics License Application (BLA) filing in Q4 2026, with a potential approval decision and platform designation expected in 2027, alongside anticipated data release from the Surfactant Bladder Rinse cohort in mid-2027.
**Commercial Outlook & Pricing:** The company projects a potential net sales target of $1 billion with approximately 2,000 patients, assuming a net price of $545,000 per year per patient (derived from a $650,000–$700,000 WAC) and payer coverage parity with new therapies under NCCN guideline category 2A designation.
**Strategic Differentiation:** Detalimogene is positioned as the only non-viral investigational gene therapy for NMIBC, featuring a proprietary DDX platform with low cost of goods, no specialized storage requirements, and a new surfactant combination that reduces dwell time from 60 to 30 minutes while increasing gene expression.